HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

K103824 · The Binding Site · CFN · Feb 27, 2012 · Immunology

Device Facts

• Record ID: K103824
• Device Name: HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
• Applicant: The Binding Site
• Product Code: CFN · Immunology
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAplus turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Device Story

Immunoturbidimetric assay for quantitative determination of human IgA in serum, lithium heparin, or EDTA plasma. Anti-IgA antibodies react with sample antigen to form antigen/antibody complexes; complex formation measured turbidimetrically via Binding Site SPAPLUS analyzer. Used in clinical laboratory settings by trained personnel. Output provides IgA concentration levels; results used by clinicians alongside other clinical/laboratory findings to diagnose abnormal protein metabolism and immunodeficiency. Modifications include expanded low-level measurement range (0.02-0.7g/L) via neat sample dilution and reduced sample volume (8 µL) to meet ESID guidelines for immunodeficiency screening; improved antigen excess capacity (40g/L).

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance comparison to predicate device.

Technological Characteristics

Turbidimetric immunoassay. Reagents: monospecific sheep anti-IgA antisera, reaction buffer, calibrators, controls. Preservatives: sodium azide, EACA, benzamidine. Measuring range: 0.02–28.0 g/L. Instrument: SPAplus turbidimetric analyzer. Traceability: ERM-DA470k. Software: Automated calculation of concentration via calibration curve.

Indications for Use

Indicated for quantitative in vitro determination of human IgA in serum, lithium heparin, or EDTA plasma to aid in diagnosis of abnormal protein metabolism and immune resistance deficiencies.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Roche Tina-quant IgA Gen.2/ Hitachi (k040435)

Submission Summary (Full Text)

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Page 1 of 2 Date prepared 02 November 2010

## 510 (k) Summary- Human IgA Liquid Reagent Kit for use on the SPAPLUS

According to the requirements of 21·CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Human IgA Liquid Reagent Kit for use on the SPAPLUS Proprietary name: IgA antigen, antiserum and control Classification name:

Submitter

The Binding Site P.O Box 11712 Birmingham B14 4ZB Tel: [phone] Suzanne Horne

Contact

The Binding Site Human IgA Liquid Reagent Kit for use on the Device description: SPAPLUS is an immunoturbidimetric assy. Anti-IgA antibodies react with antigen in the sample to form antigen/antibody complex which is measured turbidimetrically.

Intended Use:

The kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser.

8 2 7 2012

Predicate device

We claim substantial equivalence to the Roche IgA Tina Quant Gen 2. on the Modular P( K040435) which measures low level IgA.

Similarities and differences to the predicate device

| Topic | Predicate Device (K040435) | Modified Device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Intended<br>Use | The kit is intended for the<br>quantitative determination of human<br>IgA in serum and plasma using a<br>turbidimetric analyser. | Same |
| Method | Immunoturbidimetric assay | Same |
| Sample<br>type | Serum<br>Plasma - Heparin and EDTA | Same |
| Measuring<br>range | 0.05-45.0g/L (with extended rerun) | 0.02-28g/L (with rerun at neat sample<br>dilution) |
| Antigen<br>excess | 30g/L | 40g/L |

The fundamental scientific technology of the modified product is unchanged.

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### Page 2 of 2

・ ﺳﺮﯾ

Date prepared 02 November 2010

## Modifications

- An additional low level range at a neat sample dilution (0.02- 0.7g/L) has been . added to allow samples to be measured below 0.2g/L because the European Society for Immunodeficiencies (ESID) guidelines recommend that samples should be measured down to at least 0.07g/L in order to determine immunodeficiency. (ESID - European Society for Immunodeficiencies)
- The sample volume has changed from 25 µL to 8µL to allow the sample to be run . at neat
- The antigen excess capacity of the kit has been improved to 40g/L. .

The package insert has been updated to include the kit modifications.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

The Binding Site c/o Ms. Suzanne Horne Regulatory Affairs P.O. Box 11712 Birmingham, Westlands, B14 4ZB, UK

FEB 2 7 2012

## Re: k103824

Trade/Device Name: Human IgA Liquid reagent kit for use on SPAPlus™ Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test system Regulatory Class: Class II Product Code: CFN Dated: December 10, 2011 Received: January 23, 2012

Dear Ms. Horne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). und Cosmetic Fee (110) that the device, subject to the general controls provisions of the Act. The I ou may, merelere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional controls. Extraing major 1991. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I coclar surated and regeranents, including, but not limited to: registration and listing (21 Colliply with an the Fict of required 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practices and medical device-lefated develop evelity systems (OS) regulation (21 CFR Part 820). This letter requirements as set form in the quars) adevice as described in your Section 510(k) premarket win anow you to ogin marketing of substantial equivalence of your device to a legally marketed

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Page 2 - Ms. Suzanne Horne

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

of

Reena Philip

Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K/03824

Device Name: Human IgA liquid reagent kit for use on the SPAPLUS

Indications for Use: This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

hm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)/03824

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